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A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Apixaban
Apixaban
Warfarin sodium
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 20 years outpatient (regardless of sex)
  • Patients diagnosed as non-valvular atrial fibrillation (NVAF)
  • One or more following risks of stroke.

Exclusion Criteria:

  • Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
  • Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
  • Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Apixaban 5mg BID

Apixaban 2.5mg BID

Warfarin

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.

Secondary Outcome Measures

Number of Participants With Total Bleeding Events During the Treatment Period
Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.
Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period
Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.
Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period
Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.

Full Information

First Posted
November 5, 2008
Last Updated
April 23, 2013
Sponsor
Pfizer
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00787150
Brief Title
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Official Title
A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban 5mg BID
Arm Type
Experimental
Arm Title
Apixaban 2.5mg BID
Arm Type
Experimental
Arm Title
Warfarin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Apixaban 5 mg tablet BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Apixaban 2.5 mg tablet BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Warfarin sodium
Intervention Description
At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
Description
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With Total Bleeding Events During the Treatment Period
Description
Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.
Time Frame
Baseline to Week 12
Title
Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period
Description
Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.
Time Frame
Baseline to Week 12
Title
Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period
Description
Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
Time Frame
Baseline to Week 12
Title
Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period
Description
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Time Frame
Baseline to Week 12
Title
Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period
Description
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Time Frame
Baseline to Week 12
Title
Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period
Description
The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.
Time Frame
Baseline to Week 12
Other Pre-specified Outcome Measures:
Title
Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
Description
Sample at 4 hours postdose was to be taken if possible.
Time Frame
0, 2, 4 hours postdose at Week 1 and Week 8
Title
Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
Description
Sample at 4 hours postdose was to be taken if possible.
Time Frame
Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Title
Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
Description
Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.
Time Frame
Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Title
Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
Description
Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.
Time Frame
Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Title
Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
Description
Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.
Time Frame
Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
Title
Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
Description
Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.
Time Frame
Week 0, Week 1, Week 8
Title
Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
Description
Below the limit of quantification (BLQ) was assigned the value 0 for calculation.
Time Frame
Week 0, Week 1, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 20 years outpatient (regardless of sex) Patients diagnosed as non-valvular atrial fibrillation (NVAF) One or more following risks of stroke. Exclusion Criteria: Recent cerebral infarction (includes TIA) within 4 weeks of week 0. Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included). Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Seto
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Touon
State/Province
Ehime
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ogaki
State/Province
Gifu
Country
Japan
Facility Name
Pfizer Investigational Site
City
Isezaki
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shibukawa
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Higashiibaraki-gunn Ibarakimachi
State/Province
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Zentsuji
State/Province
Kagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Iwakuni
State/Province
Yamaguchi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumamoto
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21670542
Citation
Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. doi: 10.1253/circj.cj-10-1183. Epub 2011 Jun 14.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0661003&StudyName=A%20Phase%202%20Study%20To%20Evaluate%20The%20Safety%20Of%20Apixaban%20In%20Atrial%20Fibrillation
Description
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A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

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